1. Field of the Disclosure
This disclosure relates generally to hemostatic clips used to ligate or clamp blood vessels during surgical procedures and more particularly, to a cartridge for securely retaining a plurality of preformed hemostatic clips prior to the withdrawal of the clips by a clip applicator. Even more particularly, the disclosure relates to a cartridge where the cartridge has a feature that is altered by the clip loading into the applicator process resulting in a pronounced visible indicator that the applicator has been inserted and removed from the individual compartment.
2. Related Art
Hemostatic clips are a well known practice and have been used in surgery for over 75 years in the strangulation of blood vessels and other fluid ducts. The clips are permanently implanted in the body and are typically formed in a “V” or “U” shape as described in Wood—U.S. Pat. Nos. 3,326,216 and 3,363,628. Regardless of shape, the basic clip has two legs originating from a central apex.
In a prior art cartridge, Peiffer—U.S. Pat. Nos. 4,936,447 and 4,972,949, a plurality of clips is retained in place on a center, fixed pedestal by flexible retaining fingers pressing against the exterior surface of the clips legs. The use of flexible fingers was advantageous in that it provided an effective way of securing the clip and allowed the user to load clips into the applicator using a single hand. The use of retaining fingers to secure the clip results in a portion of the clip being obscured by the retaining fingers and the user can not easily determine if a clip is present in the individual compartment. Clip detection is further impeded by the use of flexible fingers that return to their original location after a clip is removed by an applicator and the small size of the clips used to ligate vessels. Clip detection is further impeded by the individual compartment design which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. The prior art does not provide for a pronounced cartridge feature change resulting from the clip loading into the applicator process. Absence of a pronounced cartridge feature change creates a user nuisance as the user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment. Failure to confirm clip presence could result in user nuisance due to wasted time as the user attempts to pick up a clip from an empty individual compartment, a worse scenario of the user believing they had picked-up and retracted a clip only to notice it missing at time of application, thus delaying the procedure while the user searches for the “lost” clip in the patient which they will never find, or the worst scenario of causing patent injury where the user, who erroneously thinks they have picked up a clip, closes an empty applicator on a vessel resulting in an unplanned severance of the vessel. To compensate for the lack of a pronounced cartridge feature change, the prior art provided for such a cartridge wherein the base is made of a light colored material and the retaining fingers are made of a dark colored material to help facilitate detection of empty individual compartments.
In Reimels—U.S. Pat. No. 3,713,533, a plurality of “V” shaped clips is retained in place on a center, fixed pedestal by placing the ends of the clips under the shoulder of housing. The use of the housing was advantageous in that it provided an effective way of securing the clip and it allowed the ability for the user to load clips into the applicator using a single hand. Using the clip ends to secure the clip does not result in a pronounced cartridge feature change as part of the clip loading into the applicator process and the user can not easily determine if a clip is present in the slot due to the small size of the clips. Clip detection is further impeded by the individual compartment design which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. Absence of a pronounced cartridge feature change creates a user nuisance as the user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment.
In Wood—U.S. Pat. No. 3,326,216, a plurality of clips is retained by press fitting the clip over a rigid, fixed pedestal with the resulting friction force on the internal surface of the clip securing the clip to the cartridge. Although the complete clip exterior is exposed, the small size of the clip does not provide an easily detectable method to determine if a clip had been previously removed and no pronounced cartridge feature change occurs as part of the clip loading into the applicator process. The user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment. Clip detection is further impeded by the individual compartment design which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process.
In other prior art such as Carroll et al. —U.S. Pat. No. 4,076,120, Samuels et al.—U.S. Pat. No. 4,146,130, Raczkowski et al. —U.S. Pat. No. 4,212,390, Samuels—U.S. Pat. No. 4,696,396, Kulp—U.S. Pat. No. 4,961,499, Appleby—U.S. Pat. No. 5,908,430, and Esposito et al. —U.S. Pat. No. 6,044,971, a plurality of clips is held in place by the legs, face or top of the clip contacting features formed into the clip compartment walls The use of a clip compartment wall feature to secure the clip impedes clip detection by adding an additional feature to the individual compartment which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. In all cases, no pronounced cartridge feature change occurs as part of the clip loading into the applicator process and the user can not easily determine if a clip is present in the slot due to the small size of the clip. Absence of a pronounced cartridge feature change creates a user nuisance as the user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment.
In Jewusiak et al.—U.S. Pat. No. 4,294,355, a plurality of clips is held in place by a film secured by a cover plate to hold clips in place. This film is weakened along the centerline of the clips. As the applicator is inserted into an individual compartment, it ruptures the film so the clip can be removed. A film or tape covering to secure clips is also present in Samuels et al.—U.S. Pat. No. 4,146,130. The use of film/tape may create a cartridge feature change as part of the clip loading into the applicator process, but without a feature to lock the ruptured film/tape in a new location the inherit memory of film/tape may result in the film/tape returning to its original location thus obscuring the individual compartment and making it difficult to detect an empty individual compartment. The prior art does not provide for a locking feature. Clip detection is further impeded by the individual compartment design which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. The use of film/tape creates other concerns. In a later patent, Samuels—U.S. Pat. No. 4,696,396, by the same inventor as U.S. Pat. No. 4,146,130, the inventor describes a problem with tape. According to this second patent the tape described in the first patent may stick to the clip when the clip is being removed. Additionally, the use of film/tape may generate particulate as part of the rupture process increasing the potential of placing film/tape particulate in the patient.
In Mericle—U.S. Pat. No. 4,361,229, a plurality of plastic clips with bosses is held in place by fingers on the side of the cartridge that engage the clip bosses and operates in principle very similar to Peiffer—U.S. Pat. No. 4,936,447. The use of retaining fingers to secure the clip results in a portion of the clip being obscured by the retaining fingers and the user can not easily determine if a clip is present in the individual compartment. Clip detection is further complicated by the use of flexible fingers that return to their original location after a clip is removed by an applicator. Clip detection is further impeded by the individual compartment design which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. The prior art does not provide for a pronounced cartridge feature change resulting from the clip loading into the applicator process and the small size of the clips. The user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment.
In Malec et al.—U.S. Pat. No. 5,279,416, a plurality of clips is held in place by a retaining member which engages the clip ends and secures the clip in the cartridge When the applicator engages the clip, the retaining member is displaced creating a cartridge feature change. The use of individual retaining members (i.e. one per clip) creates a complex multiple piece cartridge design and increases manufacturing cost. The cartridge feature change is not pronounced as it occurs in the bottom of the individual compartment which is purposely narrow to control applicator position and alignment with the clip during the clip loading into the applicator process. The user can not easily determine if a clip is present in the slot due to the small size of the clips used to ligate vessels. The user must closely inspect the cartridge prior to loading a clip and ensure a clip is present in the individual compartment.
It is thus apparent that there is a need in the art for an improved system for transporting and supplying preformed hemostatic clips, specifically a system where the hemostatic clip cartridge has a pronounced feature change created by the clip loading into the applicator process. This pronounced feature change allowing the user to easily determine that the applicator has been previously inserted into the individual compartment thus removing the need for the user to closely inspect the cartridge for clip presence in the individual compartment.